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GSK Claims New Anitbody Drug Is Effective Against Omicron

GSK Claims New Anitbody Drug Is Effective Against Omicron

GSK has just released more data on its new COVID antibody-drug and – surprise, surprise – the company and its American partner claim there is no evidence that the drug is less effectiv

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GSK Claims New Anitbody Drug Is Effective Against Omicron

GSK has just released more data on its new COVID antibody-drug and - surprise, surprise - the company and its American partner claim there is no evidence that the drug is less effective against the omicron variant.

GlaxoSmithKline and Vir Biotechnology released the updated preclinical data early Tuesday in the US. The data showed that the pair's investigational monoclonal antibody sotrovimab continues to show "in vitro activity" against the full known omicron spike protein, according to a statement. This includes 37 identified mutations of the spike protein. Although none of this data has been published in a peer-reviewed medical journal.

The data builds on initial preclinical data released last week showing GSK's antibody drug retains in vitro activity against key individual mutations of the omicron variant.

But Tuesday's data is even more encouraging.

"Given the less than three-fold neutralization shift demonstrated in the pre-clinical pseudo- virus assay, which falls below the FDA authorized fact sheet guidance of less than a 5-fold change, we are confident that sotrovimab will continue to provide significant benefit for the early treatment of patients hoping to avoid the most severe consequences of COVID-19," said Vir CEO George Scangos.

GSK's top scientist released a similarly sunny statement.

"From the outset of our collaboration with Vir we hypothesized that sotrovimab would have a high barrier to resistance and thus could deliver best-in-class potential for the early treatment of patients with COVID-19,” said Dr Hal Barron, chief scientific officer at GSK.

"These pre-clinical data demonstrate the potential for our monoclonal antibody to be effective against the latest variant, Omicron, plus all other variants of concern defined to date by the WHO, and we look forward to discussing these results with regulatory authorities around the world."

Unfortunately for the most vulnerable patients, the benefits of sotrovimab have not been seen in patients hospitalized due to a severe case COVID. Furthermore, the drug isn't used for patients who are hospitalized or require oxygen due to the seriousness of the infection.

Sotrovimab is authorized for emergency use in the US and in Japan while temporary authorizations have been granted in a dozen countries. The companies are preparing to apply for approval in the EU as well. GSK is already filling out the application for the EMA and it has already signed an agreement with the European Commission to supply doses of sotrovimab. Additional agreements are yet to be announced due to confidentiality or regulatory requirements, the company said.

GSK and Vir have engineered "pseudo-viruses" that feature major COVID mutations and have run lab tests showing the antibody drug's efficacy at combating these viruses in a lab setting.

As we pointed out again yesterday, with little concrete data available on omicron, drug- and vaccine-makers have effectively been left to talk their books, so to speak. The big question now: will these treatments actually work in humans?

Tyler Durden Tue, 12/07/2021 - 07:02

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Science

Fake research can be harmful to your health – a new study offers a tool for rooting it out

A new screening tool to help study reviewers identify what’s fake or shoddy in research may be on the horizon. And everyday people can apply some of…

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Although most medical research is reliable, studies that are flawed or fake can lead to patients undergoing treatments that might cause harm. skynesher/E+ via Getty Images

If you are suffering with chronic pain, diabetes, heart problems or any other condition, you want to be confident that your doctor will offer you an effective treatment. You certainly don’t want to waste time or money on something that won’t work, or take something that could do you harm.

The best source of information to guide treatment is medical research. But how do you know when that information is reliable and evidence-based? And how can you tell the difference between shoddy research findings and those that have merit?

There’s a long journey to the publication of research findings. Scientists design experiments and studies to investigate questions about treatment or prevention, and follow certain scientific principles and standards. Then the finding is submitted for publication in a research journal. Editors and other people in the researchers’ field, called peer-reviewers, make suggestions to improve the research. When the study is deemed acceptable, it is published as a research journal article.

But a lot can go wrong on this long journey that could make a research journal article unreliable. And peer review is not designed to catch fake or misleading data. Unreliable scientific studies can be hard to spot – whether by reviewers or the general public – but by asking the right questions, it can be done.

While most research has been conducted according to rigorous standards, studies with fake or fatally flawed findings are sometimes published in the scientific literature. It is hard to get an exact estimate of the number of fraudulent studies because the scientific publication process catches some of them before they are published. One study of 526 patient trials in anesthesiology found that 8% had fake data and 26% were critically flawed.

As a professor in medicine and public health, I have been studying bias in the design, conduct and publication of scientific research for 30 years. I’ve been developing ways to prevent and detect research integrity problems so the best possible evidence can be synthesized and used for decisions about health. Sleuthing out data that cannot be trusted, whether this is due to intentional fraud or just bad research practices, is key to using the most reliable evidence for decisions.

Systematic reviews help suss out weak studies

The most reliable evidence of all comes when researchers pull the results of several studies together in what is known as a systematic review. Researchers who conduct systematic reviews identify, evaluate and summarize all studies on a particular topic. They not only sift through and combine results on perhaps tens of thousands of patients, but can use an extra filter to catch potentially fraudulent studies and ensure they do not feed into recommendations. This means that the more rigorous studies have the most weight in a systematic review and bad studies are excluded based on strict inclusion and exclusion criteria that are applied by the reviewers.

Systematic reviews explained.

To better understand how systematic reviewers and other researchers can identify unreliable studies, my research team interviewed a group of 30 international experts from 12 countries. They explained to us that a shoddy study can be hard to detect because, as one expert explained, it is “designed to pass muster on first glance.”

As our recently published study reports, some studies look like their data has been massaged, some studies are not as well designed as they claim to be, and some may even be completely fabricated.

Our study provides some important ideas about how to spot medical research that is deeply flawed or fake and should not be trusted.

The experts we interviewed suggested some key questions that reviewers should ask about a study: For instance, did it have ethics approval? Was the clinical trial registered? Do the results seem plausible? Was the study funded by an independent source and not the company whose product is being tested?

If the answers to any of these questions is no, then further investigation of the study is needed.

In particular, my colleagues and I found that it’s possible for researchers who review and synthesize evidence to create a checklist of warning signs. These signs don’t categorically prove that research is fraudulent, but they do show researchers as well as the general public which studies need to be looked at more carefully. We used these warning signs to create a screening tool – a set of questions to ask about how a study is done and reported – that provide clues about whether a study is real or not.

Signs include important information that’s missing, like details of ethical approval or where the study was carried out, and data that seems too good to be true. One example might be if the number of patients in a study exceeds the number of people with the disease in the whole country.

Spotting flimsy research

It’s important to note that our new study does not mean all research can’t be trusted.

The COVID-19 pandemic offers examples of how systematic review ultimately filtered out fake research that had been published in the medical literature and disseminated by the media. Early in the pandemic, when the pace of medical research was accelerating, robust and well-run patient trials – and the systematic reviews that followed – helped the public learn which interventions work well and which were not supported by science.

For example, ivermectin, an antiparasitic drug that is typically used in veterinary medicine and that was promoted by some without evidence as a treatment for COVID-19, was widely embraced in some parts of the world. However, after ruling out fake or flawed studies, a systematic review of research on ivermectin found that it had “no beneficial effects for people with COVID-19.”

On the other hand, a systematic review of corticosteroid drugs like dexamethasone found that the drugs help prevent death when used as a treatment for COVID-19.

There are efforts underway across the globe to ensure that the highest standards of medical research are upheld. Research funders are asking scientists to publish all of their data so it can be fully scrutinized, and medical journals that publish new studies are beginning to screen for suspect data. But everyone involved in research funding, production and publication should be aware that fake data and studies are out there.

The screening tool proposed in our new research is designed for systematic reviewers of scientific studies, so a certain level of expertise is needed to apply it. However, using some of the questions from the tool, both researchers and the general public can be better equipped to read about the latest research with an informed and critical eye.

Lisa Bero is Senior Editor, Research Integrity for Cochrane, an international non-profit organization that publishes systematic reviews.

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Government

Pfizer Inc (NYSE: PFE) To Acquire Global Blood Therapeutics For $5 Billion

According to sources familiar with the matter, the Wall Street Journal reported that Pfizer Inc (NYSE: PFE) was in advanced discussions to acquire pharmaceutical…

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According to sources familiar with the matter, the Wall Street Journal reported that Pfizer Inc (NYSE: PFE) was in advanced discussions to acquire pharmaceutical company Global Blood Therapeutics (NASDAQ: GBT) for $5 billion.

Pfizer, too, acquired Global Blood Therapeutics 

Pfizer wants to close a deal soon, but there are still other interested parties, according to the article.

Global Blood Therapeutics, which manufactures Oxbryta, the blood disorder medication, saw its shares jump 44%  on Friday afternoon to a two-year high. As of Thursday’s closing, the company’s market cap was $3.12 billion.

A spokesman for Global Blood stated the company does not “comment on market rumors or speculation,” while Pfizer declined to respond on the matter.

With plenty of cash left over after selling its COVID-19 vaccine, New York-based Pfizer is searching for deals that may generate billions of dollars annual sales by 2030.

Its $11.6 billion acquisition of migraine medication manufacturer Biohaven Pharmaceutical Holding (NASDAQ: BHVN) in May was the most recent in a series of purchases that also included Trillium Therapeutics and Arena Pharmaceuticals in recent years.

Oxbryta received approval last year for sickle cell disease management 

In 2019, the US government approved Global Blood’s Oxbryta to manage sickle cell disease in individuals aged 12 and over. The oral medication was approved in December 2021 to treat the illness in younger children. The drug’s sales increased by almost 50% to $194.7 million in 2021.

After a gloomy start to the calendar year, when a lack of significant purchases and clinical-stage treatment failures lowered investor morale and restricted funding, the biotech dealmaking pace has recently picked up again.

Also, Amgen Inc (NASDAQ: AMGN) also decided to purchase ChemoCentryx Inc on Thursday for $3.7 billion to obtain access to a possible breakthrough medication for inflammatory illnesses. AstraZeneca’s $39 billion acquisition of Alexion Pharmaceuticals in 2020 has put the realm of immune diseases in the limelight. The deal, which was announced before trading opened, will also give the corporation control of at least two investigational immune disorders medicines.

Please make sure to read and completely understand our disclaimer at https://www.wallstreetpr.com/disclaimer. While reading this article one must assume that we may be compensated for posting this content on our website.

The post Pfizer Inc (NYSE: PFE) To Acquire Global Blood Therapeutics For $5 Billion appeared first on Wall Street PR.

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Spread & Containment

UBC researchers discover ‘weak spot’ across major COVID-19 variants

Researchers at the University of British Columbia have discovered a key vulnerability across all major variants of the SARS-CoV-2 virus, including the…

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Researchers at the University of British Columbia have discovered a key vulnerability across all major variants of the SARS-CoV-2 virus, including the recently emerged BA.1 and BA.2 Omicron subvariants.

Credit: Dr. Sriram Subramaniam, UBC

Researchers at the University of British Columbia have discovered a key vulnerability across all major variants of the SARS-CoV-2 virus, including the recently emerged BA.1 and BA.2 Omicron subvariants.

The weakness can be targeted by neutralizing antibodies, potentially paving the way for treatments that would be universally effective across variants.

The findings, published today in Nature Communications, use cryo-electron microscopy (cryo-EM) to reveal the atomic-level structure of the vulnerable spot on the virus’ spike protein, known as an epitope. The paper further describes an antibody fragment called VH Ab6 that is able to attach to this site and neutralize each major variant. 

“This is a highly adaptable virus that has evolved to evade most existing antibody treatments, as well as much of the immunity conferred by vaccines and natural infection,” says Dr. Sriram Subramaniam (he/him), a professor at UBC’s faculty of medicine and the study’s senior author. “This study reveals a weak spot that is largely unchanged across variants and can be neutralized by an antibody fragment. It sets the stage for the design of pan-variant treatments that could potentially help a lot of vulnerable people.”

Identifying COVID-19 master keys

Antibodies are naturally produced by our bodies to fight infection, but can also be made in a laboratory and administered to patients as a treatment. While several antibody treatments have been developed for COVID-19, their effectiveness has waned in the face of highly-mutated variants like Omicron.

“Antibodies attach to a virus in a very specific manner, like a key going into a lock. But when the virus mutates, the key no longer fits,” says Dr. Subramaniam. “We’ve been looking for master keys — antibodies that continue to neutralize the virus even after extensive mutations.”

The ‘master key’ identified in this new paper is the antibody fragment VH Ab6, which was shown to be effective against the Alpha, Beta, Gamma, Delta, Kappa, Epsilon and Omicron variants. The fragment neutralizes SARS-CoV-2 by attaching to the epitope on the spike protein and blocking the virus from entering human cells.

The discovery is the latest from a longstanding and productive collaboration between Dr. Subramaniam’s team at UBC and colleagues at the University of Pittsburgh, led by Drs. Mitko Dimitrov and Wei Li. The team in Pittsburgh has been screening large antibody libraries and testing their effectiveness against COVID-19, while the UBC team has been using cryo-EM to study the molecular structure and characteristics of the spike protein.

Focusing in on COVID-19’s weak points

The UBC team is world-renowned for its expertise in using cryo-EM to visualize protein-protein and protein-antibody interactions at an atomic resolution. In another paper published earlier this year in Science, they were the first to report the structure of the contact zone between the Omicron spike protein and the human cell receptor ACE2, providing a molecular explanation for Omicron’s enhanced viral fitness.

By mapping the molecular structure of each spike protein, the team has been searching for areas of vulnerability that could inform new treatments.

“The epitope we describe in this paper is mostly removed from the hot spots for mutations, which is why it’s capabilities are preserved across variants,” says Dr. Subramaniam. “Now that we’ve described the structure of this site in detail, it unlocks a whole new realm of treatment possibilities.”

Dr. Subramaniam says this key vulnerability can now be exploited by drug makers, and because the site is relatively mutation-free, the resulting treatments could be effective against existing—and even future—variants.

“We now have a very clear picture of this vulnerable spot on the virus. We know every interaction the spike protein makes with the antibody at this site. We can work backwards from this, using intelligent design, to develop a slew of antibody treatments,” says Dr. Subramaniam. “Having broadly effective, variant-resistant treatments would be a game changer in the ongoing fight against COVID-19.”


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